It’s American Heart Association Scientific Sessions week, so unsurprising to see companies pointing us at supportive clinical data, presented at the event. One such St. Jude Medical, Inc., has announced a retrospective data analysis from a study into its CardioMEMS™ HF monitoring sensor. The CHAMPION clinical trial showing significant a reduction in 30-day hospital readmission rates for patients age 65 and older.

Background

Heart failure (HF) occurs when the heart is unable to pump enough blood to meet the body’s demands and blood pressure within the heart is elevated. Significant HF progression over a period of days is known as acute decompensation and leads to hospitalization. Increased Pulmonary Artery (PA) pressures often precede indirect measures of worsening HF such as weight and blood pressure changes. St. Jude’s CardioMEMS HF System allows clinicians to stabilize PA pressures by proactively managing medications and other treatment options while also providing an early indication of worsening HF.

Acquired by St. Jude in May 2014, the CardioMEMS system uses a miniaturized, wireless monitoring sensor that is implanted in the PA using a minimally invasive procedure to directly measure PA pressure. This measure allows clinicians to proactively manage treatment with medication changes for patients with worsening HF before visible symptoms, such as weight and blood pressure changes, occur. The system allows patients to transmit PA pressure data from their homes to their health care providers, who then manage appropriate medication changes to reduce the likelihood of hospitalization.

The CHAMPION trial looked at the safety and effectiveness of the CardioMEMS™ HF System for patients with New York Heart Association (NYHA) Class III HF who had been hospitalized for HF in the previous 12 months. The analysis was entitled ‘Impact of Wireless Pulmonary Artery Pressure Monitoring on Heart Failure Hospitalization and All-Cause 30-Day Readmissions in Medicare-Eligible patients with NYHA Class III Heart Failure.” It looked at patients 65 and older (Medicare-eligible) from the CHAMPION trial and found that there was a 58 percent reduction in all-cause hospital readmissions (hospitalization for any reason) and a 78 percent reduction in HF hospital readmissions when patients were managed with the CardioMEMS HF System compared to standard-of-care medical management. These findings suggest that use of the CardioMEMS HF System can significantly reduce the hospital’s risk of government-imposed penalties that are designed to reduce patient readmissions within 30 days of treatment.

Investigator comments

“Incorporating proactive pulmonary artery pressure monitoring into patient management significantly reduced heart failure hospitalizations and 30-day all-cause and HF readmissions in patients age 65 and older. The adoption of this treatment strategy using the CardioMEMS HF System addresses the unmet need within the U.S. health care system for hospitals struggling to meet the requirements of CMS,” said Dr. Philip Adamson, MC Director of the Heart Failure Institute at Oklahoma Heart Hospital in Oklahoma City.

Company comments

“These data are recognition of the importance the CardioMEMS HF System brings to heart failure patients burdened with multiple hospital admissions each year and the cost-savings it brings to the health care system,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “We continue our commitment of investing in meaningful clinical research with this new data analysis from the CHAMPION trial that is helping shape the way physicians are caring for their patients.”